DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
FDA device recall Z-3171-2024 · posted 2024-09-19 · Open, Classified
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- Reason for recall
- Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.
- Action taken
- Smith & Nephew issued and Urgent Medical Device Recall Notice to its consignees on 07/09/2024 via overnight mail. The notice explained the problem, potential risk, and requested the return of the product. Sales representatives, District Offices, and/or Distributors were directed to notify their customers. For questions or concerns regarding this recall please contact FieldActions@smith-nephew.com.
- Root cause
- Packaging change control
- Status
- Open, Classified
- Product code
- HTY
- Quantity affected
- 24 units
- Distribution
- US, Canada, Norway
- Date initiated
- 2024-07-09
- Date posted
- 2024-09-19
- Location
- Memphis, TN
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